Expert Review Panel for Diagnostics - Lessons Learnt

Transcription

1 Expert Review Panel for Diagnostics - Lessons Learnt Dr. Mariatou Tala Jallow, Head, Sourcing and Procurement of Health Products November 2015 Copenhagen

2 What is the Expert Review Panel for Diagnostics (ERPD) Mechanism integrated in the QA Policy for Diagnostics (adopted Dec 2010 & reviewed Feb 2014) based on previous experience with ERP for medicines. The products requiring review by the ERPD would be limited to products that may have a high public health impact, but have not yet undergone a stringent regulatory assessment. ERPD mechanism should help to expedite access to innovative diagnostic products, if the associated risks are deemed less than the potential benefits. ERPD is hosted by WHO as requested by Global Fund s Board. UNITAID also committed to support the current ERPD The Global Fund, UNITAID and their technical partners determine the product scope of each ERPD based on public health needs

3 ERPD: Purpose To assess the potential risks/benefits associated with the procurement of diagnostic products that may have a high public health impact, but have not yet undergone a stringent assessment, either by WHO Prequalification or by a SRA. To advise the Global Fund/UNITAID in their decision on whether to allow grant funds to be used for the time-limited procurement of the diagnostics reviewed by the ERPD. Additional key partners also consider the outcomes of the ERPD to determine acceptability for procurement. The time limited period granted for procurement is usually 12 months ERPD risk/benefit assessment does not replace WHO PQ/ SRA assessment, but should be seen as a step towards a WHOPQ/full regulatory review.

4 Summary of Expert Review Panel for Diagnostics process 1 Key steps Development and publication of Expression of Interest (EOI) Responsible party Global Fund 2 Receiving and screening of submissions to determine eligibility for ERPD Global Fund ERP for Diagnostics 3 Organizing the assessment by a panel of experts WHO 4 5 Preparing the ERPD Reports and providing conclusions based on experts ' advice to GF/UNITAID Dissemination of ERPD outcomes to manufacturers WHO Global Fund

5 Documentation submitted by manufacturers for an ERPD review as per EoI requirements 1. A cover letter expressing interest to submit to ERPD for review, 2. A letter from the WHO Prequalification Programme or from a SRA confirming that the product is currently under review for the intended use, or In the absence of such a confirmation letter, a letter of commitment from the manufacturer to submit product dossier either to WHO prequalification or to an SRA, 3. QMS documents substantiated by one or two most recent and valid inspection reports, 4. An abbreviated product dossier as per generic instructions outlined in the EoI Annex 1.

6 Technical Areas of ERPD review: Questionnaire and supporting documents Product regulatory version and description Labelling Design and manufacturing information Quality Management System Commercial history, customer support Product performance specifications, associated validations and verification studies

7 Categorization of products reviewed by ERPD Classification of products reviewed in four categories: Products classified in Categories 1 and 2 may be considered for time-limited procurement. Products classified in Category 3 may be considered for time- limited procurement only if there is no other option and the risk of not diagnosing and/or making treatment decisions is higher than the risk of using the product. Products classified in Category 4 may not be considered for procurement under any circumstances.

8 ERPD: Operationalization ERPD pilot : Q1/Q _ HIV EID technologies. Two submissions ERPD 1 : Q3/Q _ POC CD4 and HIV EID, HIV VL, HIV molecular DBS Seventeen submissions of which 7 not accepted for various reasons ERPD 2: Q1/Q2 2015_ HIV molecular DBS and Hepatitis C all formats Five submissions ERPD 3: Q3/Q4 2015_ HCV RDTs, syphilis RDTs and multi analyte RDTs, HIV combined with hepatitis C or B. Thirteen submissions Outcomes rounds 1+2: Two products eligible for procurement (risk category 1&2), three products eligible for ad hoc procurement (risk category 3).

9 Lessons learnt Advise to Manufacturers Periodically check the Global Fund website for publication and any relevant updates Submit only in-scope products for the current EOI. One submission for one product Provide electronic submissions and hardcopy of the information /data on time Maximally utilize the outcomes and/or advice from the assessment Inform the Global Fund of any variations

10 Areas for improvements have been identified in the current ERPD process Improve the consultative process which involves more and more partners Design and Publication of Expression of Interest Develop new EOI criteria and provide clearer instructions with regards to product eligibility for a given ERPD round Proactively engage with manufacturers and improve the visibility of the current EOI publication Receivability of the questionnaire and screening Strenghten the scrutiny of the screening process to identify to ensure eligibility and identify critical missing information Provide more clearer guidance on how to fill the product questionnaire and on the norms and standards to be used One product = One questionnaire Provide feedback to WHO on the missing element or supplement with regards to existing guidance or standard

11 Areas for improvements have been identified in the current ERPD ERP assessment by experts panel Provide more guidance to reviewers in terms of public health impact of the products Improve the reporting format to better align order of documents with the report structure Some suggestions to increase the granularity of the risk categories. Initial Decisions and maintenance Distribution of the full ERPD report with manufacturers, instead of the summary findings was well received, and will be continued Amend the notification letter to be more specific in recalling their responsibilities regarding reporting variations and post-marketing issues Dissemination of outcomes Sharing ERP outcomes with specific partners as per agreement by the manufacturer in the signed questionnaire will be continued and expanded Strenghten confidentiality agreement between the various institutions Improve the communication and publication of the ERPD decisions for Categories 1 & 2

12 Next Steps 2016 Scheduled next EoI for ERPD : End January 2016 GF/UNITAID will determine product scope next ERPD New EoI will be issued beginning of February nd EoI will be issued July Manufacturers meeting for information sharing in Q3-Q Up-dates on Global Fund/UNITAID websites

13 Conclusion: ERPD as a single mechanism used by multiple stakeholders The ERPD is designed to: Be a single expert review mechanism intended to be endorsed and used by multiple stakeholders and avoid unnecessary duplication, Promote harmonization of quality standards for the time-limited procurement of needed diagnostic products, prior to their full assessment by WHO or SRA, Promote the rational use of scarce expertise and resources The ERPD sponsors (Global Fund/UNITAID) encourages stakeholders to seek advice from them on: Time-limited procurement of diagnostic products Identifying specific priority products to be reviewed by ERPD.

14 Alain Prat Specialist Quality Assurance Health Product Management Hub Grant Management Support Department